BioNTech SE

Medical Director

• Develop scientific content in the field of COVID-19.
• Develop scientific material for internal training and external engagement activities with key stakeholders based on most recent data.
• Generate insights on unmet medical need based on scientific publications, conferences and new clinical development strategies in the therapeutic area.
• Provide Medical Affairs analysis for developing medical strategies for specific assets/indications in the BNT portfolio.
• Support evidence generation and global clinical/medical-driven studies in close collaboration with our partners.
• Provide medical input to cross-functional teams.
• Work closely with local Medical Affairs associates to ensure alignment of global medical strategy with local insights and requirements.
• Work closely with clinical development and regulatory affairs teams to ensure alignment of medical strategies and clinical development plans.
• Analyze and interpret clinical trial data and communicate findings to internal and external stakeholders.
• Provide medical expertise to support product launch and post-marketing activities.

Associate Director, Global Medical Affairs – 2-year contract

Product Manager

• Develop and execute the strategic roadmap for ERP Controlling systems
• Design and coordinate implementation of technical solutions ensuring optimal functionality and integration
• Drive alignment with cross-functional business objectives and ensure smooth operational integration
• Manage and support changes, business projects and roll-out projects from initial planning to execution
• Drive innovation and introduce new features to support and achieve business targets
• Collaborate seamlessly with process owners, ERP Applications leadership, program teams and external partners

Senior Product Owner, SAP CO

Chief Marketing Officer

• Drive the development and implementation of category strategies in collaboration with business stakeholders, such as CMC, ESO, Supply Chain, Legal and QA.
• Identify and assess global business needs, proactively engaging with the business to achieve company objectives.
• Manage demand and identify opportunities for cost optimization and procurement process improvements.
• Integrate company requirements into supplier sourcing, selection, and contracting
• Lead supplier contract negotiations and manage contract life cycles.
• Analyze and track procurement/supplier data for better decision-making.
• In close collaboration with CMC and ESO, improve supplier performance and mitigate risks, such as geopolitical, financial or compliance risks
• Oversee supplier lifecycle, from approval to offboarding, aligned with business stakeholders
• Ensure governance and compliance in strategic procurement, adhering to internal policies and external regulations.
• Translate program plans and needs into actionable procurement strategies in alignment with other procurement category teams.
• Serve as the central point of contact for program management inquiries and ensure transparency and efficiency in procurement activities.
• Initiate and lead cross-category meetings to ensure cohesive procurement strategies.
• Report program status updates to the VP Global Procurement and escalate critical topics as needed.

Director, Program and Production Procurement – CDMO / CMO

• Lead the design of clinical trials by developing study protocols and selecting endpoints
• Provide strategic oversight for clinical trial execution and monitor study progress
• Drive the creation of key study-level documents such as protocols and regulatory submissions
• Address regulatory/health authority inquiries and ensure compliance with guidelines
• Develop and oversee the Clinical Development Plan and Integrated Evidence Plan
• Collaborate with cross-functional teams to ensure seamless execution of clinical development programs
• Mentor junior team members within the clinical science organization

Director, Clinical Science

QA Engineer

• Supports and oversees the proactive and risk-based quality strategy implementation in the drug research and development activities
• contributes to a culture of quality in BioNTech GDO China to positively impact the business and implement the overall strategy and vision of the Quality Organization
• collaborates with key stakeholders to execute the company & department strategy, follow proactive and risk-based quality approaches, leverage Quality by Design principles, and provides QA & GCP expertise and guidance to achieve GDQA CN goals and company objectives
• puts efforts to work with other GDQA CN team members, while continuously upholding the principles of transparency, speak up, and proactivity
• participate in the quality projects according to quality plan under GDQA CN LT oversight for the continuous improvement initiatives
• ensures that a proactive, risk-based Quality Strategy is established and implemented for trials assigned
• collaborates with key internal stakeholders to ensure that clinical trial risks are detected and remediated and deviations / quality issues identified are adequately investigated
• maintains a state of inspection readiness/quality dashboard that outlines key quality aspects

Associate Director, Clinical Quality Assurance Compliance

• Drive the development and implementation of category strategies in collaboration with business stakeholders
• Identify and assess global business needs, proactively engaging with the business to achieve company objectives
• Manage demand and identify opportunities for cost optimization and procurement process improvements.
• Integrate company requirements into supplier sourcing, selection, and contracting
• Lead supplier contract negotiations and manage contract life cycles
• Analyze and track procurement/supplier data for better decision-making
• Improve supplier performance and mitigate risks such as geopolitical, financial or compliance risks
• Oversee supplier lifecycle from approval to offboarding
• Ensure governance and compliance in strategic procurement, adhering to internal policies and external regulations
• Translate program plans and needs into actionable procurement strategies in alignment with other procurement category teams
• Serve as the central point of contact for program management inquiries and ensure transparency and efficiency in procurement activities
• Initiate and lead cross-category meetings to ensure cohesive procurement strategies
• Report program status updates to the VP Global Procurement and escalate critical topics as needed

Director – Procurement, Program & Production

Director

• The Senior Director Global Patient Engagement & Excellence is accountable for expanding and elevating the company’s patient-centric culture worldwide.
• This role supports best-in-class processes across all geographies, implements tools, and metrics that ensure excellence in execution, and embeds patient insights into strategic decision making across the organization.
• Reporting to the VP Head of Global Medical Affairs or the ED International Markets, this role will partner closely with U.S. Patient Engagement & Advocacy, other Medical Affairs roles, Commercial, Market Access, Clinical Development, Legal/Compliance, and regional teams to ensure patients’ voices meaningfully shape our science, strategy, and solutions.
• Build and execute a global patient engagement roadmap that aligns with corporate goals and complements.
• Identify, prioritize, and cultivate relationships with international patient organizations, advocacy groups, and key opinion leaders; serve as the primary point of contact for ex-U.S. partners or key international organisations.
• Co-create patient-focused initiatives (e.g. education and research collaborations) that drive mutual value and improve patient outcomes.
• Ensure worldwide consistency in messaging, positioning, and ethical standards.

Senior Director, Global Patient Engagement, Advocacy & Excellence

• Design and implement a global Clinical Technology Vendor Governance Framework aligned with ICH GCP E6 R3 and regulatory standards.
• Oversee day-to-day vendor performance for technologies like EDC, eCOA, RTSM, eTMF, RBM, digital health solutions, and AI-driven systems.
• Define KPIs, SLAs, and metrics tied to study timelines, data quality, system performance, and delivery reliability.
• Establish robust AI governance frameworks ensuring transparency in intended use, decision boundaries, risk classification, validation processes, and lifecycle management.
• Proactively manage risks through monitoring systems while maintaining inspection readiness for regulatory audits.
• Serve as the central escalation point for issue resolution across internal teams and external vendors.
• Drive strategic oversight of technology vendors to optimize scalability and cost-efficiency while fostering trust-based partnerships.

Director, Clinical Technology Oversight Lead

Program Manager

• Responsible for the efficient end-to-end management of global R&D Programs and/or drug platforms at all development stages
• Lead program/drug platform management activities incl. planning, execution, monitoring, reporting, decision-making support
• Co-lead the development of program/drug platform strategy together with program/platform lead and core team to drive programs through milestones
• Ensure integration and execution across all functional areas in delivering the program’s or drug platform development´s goals and team’s success (scope, budget, time, quality)
• Support commercial / licensing / partnering / intellectual property activities related to the programs/drug platforms as needed
• Facilitate strong cross-functional communication by building working relationships across the organization
• Help drive a culture of achievement and accountability within teams
• Lead the implementation of new processes and process improvement initiatives within and beyond R&D Program Management department
• Lead/contribute to global drug development structure initiatives and cross-functional processes ensuring swift and seamless transition of assets through different development phases
• May build, lead and develop dedicated Project/Program Management teams incl. resource management, guiding, supervision, coaching, developing team members

Director, R&D Program Management

Strategy

• Represent the analytical function within cross-functional project teams and act as the primary interface for the CMC team and other key stakeholders.
• Coordinate analytical deliverables across internal analytical functions and external partners, ensuring alignment with the overall analytical development strategy.
• Shape and align the analytical control strategy in close collaboration with functions such as Regulatory Affairs, CMC, and Quality, ensuring compliance with regulatory expectations and health authority requirements.
• Provide leadership and oversight for analytical activities, ensuring transparent communication of progress, timelines, risks, and challenges to relevant stakeholders.
• Maintain end-to-end ownership of the analytical components of the CMC Module 3 dossier, including document preparation, review, and lifecycle maintenance.

Associate Director, Projects & Strategy, Analytical Sciences & Technology

Operations

• Execute the biomarker strategy by planning, coordinating, and overseeing biomarker sample operations throughout Phase I–IV clinical trials
• Ensure biomarker sample collection, tracking, storage, and handling are performed in compliance with the clinical trial protocol and informed consent
• Coordinate and integrate biomarker operational activities across cross ‑ functional teams
• Lead the preparation, review, and submission of HGR application documents, ensuring regulatory compliance and alignment with study requirements, as well as leading the activities of biosample exportation/importation per study requirements
• Coordinate end ‑ to ‑ end HGR submission activities across study teams, sites, and cross ‑ functional stakeholders, managing timelines, dependencies, and submission quality
• Provide operational oversight and risk awareness for HGRAC activities to support timely approvals and minimize regulatory impact on study milestones
• Deliver biomarker operational outputs on time and with high quality, in compliance with ICH/GCP requirements
• Establish and manage efficient biomarker sample logistics from study start ‑ up through data delivery and study close ‑ out
• Set up and maintain accurate tracking, reporting, and metrics for biomarker samples and related data
• Support internal teams in the selection, contracting, and qualification of biomarker vendors and central laboratories
• Oversee day ‑ to ‑ day biomarker vendor activities, including performance monitoring, issue management, and escalation
• Provide sample forecasts to support resource planning and cost estimation
• Track and manage external biomarker ‑ related costs for budgeting purposes
• Oversee biomarker sample operations for complex, multi ‑ region studies
• Take accountability for biomarker operational deliverables, study milestones, and program objectives
• Contribute to or author biomarker and laboratory manuals and other relevant documentation
• Partner with Translational Science, Clinical Operations, and other functions to identify gaps and drive process improvements
• Support the implementation of new or improved processes, including SOPs and guidance documents
• Act as the primary liaison with internal laboratories to ensure effective communication and information flow
• Provide mentoring and support to new hires

Manager, Biomarker Operations

Manager

• Lead annual budgeting, forecasting, and long-range planning processes for BNT China, with a focus on pharmaceutical operations.
• Analyze financial results, variances, and business drivers; provide actionable insights and recommendations to management.
• Prepare and present monthly management reports, dashboards, and business reviews.
• Support strategic initiatives, scenario modeling, and investment analysis.
• Ensure compliance with pharmaceutical industry regulations and internal controls.
• Plan and forecast local R&D activities (e.g., GDO function, local CRO activities of BNT programs, etc.).
• Prepare monthly actual reporting and ad-hoc analysis with the business.
• Track actual costs and monitor budgets for local spend, especially for R&D and clinical operations.
• Act as the local finance business partner to the country head, providing financial guidance and support for decision-making.
• Work closely with the Global Planning & Reporting team on processes (budgeting, forecasting, quarterly reporting, etc.) and with the Global Finance Business Partner R&D team regarding financial steering of R&D business.
• Lead or support SAP implementation, upgrades, and process optimization projects within the finance function.
• Ensure accurate data integration, reporting, and compliance in SAP, especially for pharmaceutical R&D and Clinical operational activities.
• Drive automation and digitalization initiatives to enhance efficiency and transparency in financial planning and reporting.
• Collaborate with GDO, operations, and functional teams to drive cross-functional alignment on financial targets, KPIs, and resource allocation.
• Support business case development and post-investment reviews.
• Provide financial training and guidance to non-finance stakeholders.

BPA Manager

• The Safety Strategy Lead China represents a pivotal function in the BioNTech Safety Governance
• Leads a team of safety physicians
• Ensures balancing of resources and assignment of projects across the safety physicians in his/her team
• Provides guidance and personal development for team members
• Oversees safety management team(s), responsible for the safety monitoring, benefit-risk assessments and risk management of the assigned products in development and/or marketed
• Ensures that single case reporting, signal management and risk management activities which occur under his/her direction and competence, are performed at all times in compliance with applicable law, global and local regulations and in high quality
• Is accountable for the quality and timeliness of the medical safety review of and contributions to clinical and regulatory documents concerning the portfolio products
• Is medical safety subject matter expert for the assigned products and is the arbiter for safety related issues as they may arise
• Responsible for formulating and driving the optimal development safety strategy for the products or product combinations in clinical development at the portfolio level
• Assumes accountability for the expert support to independent data and safety monitoring board(s)
• Directs safety management team(s) in formulating and maintaining a structured benefit risk assessment for each of the products in development
• May decide in consultation with the Head of Medical Safety that an emergent safety issue/product alert deserves escalation to the Executive Safety Council for arbitration and/or action
• Contributes and/or oversees delegated contributions to clinical and regulatory documents such as briefing book for regulatory authority meetings globally with focus also on local China requirements
• Represents MSPv in joint oversight committees concerning collaborative programs with development partners
• Upon request, may support business support in due diligence activities regarding review of assets of interest or asset investments/divestments
• Assumes accountability for the planning and implementation of inspection readiness

Director, Medical Safety & Pharmacovigilance, Safety Strategy Lead

• Ensure compliance with unique local regulations and BNT processes in China
• Support BNT QMS and other global GDQA functions
• Ensure proper assessment of local vendors
• Support QA to QA relationships with local service providers (CROs, Labs) and BNT Collaboration Partners
• Provide proactive local GCP compliance, guidance, and advice
• Provide local Clinical QA Compliance, audit, and inspection support to the country, leveraging other global GDQA systems (e.g., QMS) and processes
• Supports the Global development Operational functions as well as other QA groups, as necessary, for GCP Health Authorities inspection preparation/facilitation/follow-up activities, including CAPAs
• Provides appropriate and relevant quality metrics to applicable stakeholders and can perform trending of observations and the creation of key performance indicators across auditing activities
• Supports the creation and updates of the risk-based audit strategy and the derived audit plan for the functions and activities under the oversight of the Global Development QA (including GCP and GCLP)
• Coordinates and oversees the audits performed by external vendors, including acting as the interface with BioNTech internal functions involved with these audits
• Performs audits and oversees the adequate follow-up of issues identified during audits
• Drives risk-based approach using modern and novel approaches and critical thinking to solving complex business problems
• Provide input to functional teams.

Senior Manager, Global Development Quality Assurance

• Represent External QC Network at CMOs (predominantly located in China) ensuring QC and GMP requirements of BioNTech are considered
• Represent external/global QC in multidisciplinary project team and define QC project strategy in related projects
• Oversees the stability program of late development projects.
• Ensures that stability programs are implemented and adhered to and that results are reported and evaluated.
• Oversee QC activities at CDMOs and ensure delivery of QC-associated work packages (data evaluation, deviation/OOS-investigations, CoA generation and release) in time and quality
• Act as link between global External QC Network team and Chinese CMOs
• Participate in generation and approval of QC-related GMP-documentation
• Management of full QC-value chain for relevant projects/products